`Sent:
`To:
`Subject:
`
`Wed Nov 08 2006 17:46:20 EST
`bg00012 phase 3 smt;
`Fw: Biogen Idec 301 & 302/Weekly reports/8 Nov 06/TMF
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`Biogen Exhibit 2215
`Coalition v. Biogen
`IPR2015-01993
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`Project Startup Summary
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`Client:
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`Date:
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`Biogen Idec
`
`7 Nov 06
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`Protocol Number:
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`109MS301
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`VI.
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`KEY ACCOMPLISHMENTS
`
` CDA’s –245 sent out & 196 received (including those already in place)
` 192 SRQ’s sent out, 95 received back. (Please see the CSSR report for details)
` Belgium –
` has confirmed he will be the coordinating site
`
` – EC submission passed the SRC without comments, now passed onto the
`HREC for their review on 8 Nov 06
` BIIB confirmed the Health Canada submission for both the 301 & 302 studies was
`made on 7 Nov 06
` Amendment 1 ICF’s were received on 7 Nov 06, excluding MRI ICF’s
`
`VII. KEY DECISIONS
`
` Australia –
` has agreed to participate following review of the budget
`
` as LKP for Germany, BIIB have approved
` has proposed
` Belgium – we are targeting the 20 Nov for a 29 Nov EC Meeting at
` site.
` will aim to include as many sites as possible in this submission, however for any
`that are not ready for this submission an amendment may need to be made at a later
`date.
` With the addition of Brazil the projected end of site recruitment has now been agreed
`at 15 December 06
` Brazil has been added, with a target of 5 sites. Site list received from BIIB on 7 Nov
`06
` The MRI sub study will be focused on the following countries – Poland, Canada,
`Czech Republic, Hungary, Germany, UK
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